Ignite Creation Date:
2025-12-24 @ 10:17 PM
Ignite Modification Date:
2026-01-01 @ 9:16 AM
Study NCT ID:
NCT05582135
Status:
COMPLETED
Last Update Posted:
2022-10-17
First Post:
2022-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Analgesic Effect of Esketamine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009020', 'term': 'Morphine'}, {'id': 'C000629870', 'term': 'Esketamine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2022-10-13', 'lastUpdatePostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain score at rest', 'timeFrame': 'Two hours after caesarean delivery', 'description': 'The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.'}, {'measure': 'Postoperative pain score at rest', 'timeFrame': 'Four hours after caesarean delivery', 'description': 'The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.'}, {'measure': 'Postoperative pain score at rest', 'timeFrame': 'Eight hours after caesarean delivery', 'description': 'The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.'}, {'measure': 'Postoperative pain score at rest', 'timeFrame': 'Twelve hours after caesarean delivery', 'description': 'The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.'}, {'measure': 'Postoperative pain score at rest', 'timeFrame': 'Twenty-four hours after caesarean delivery', 'description': 'The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.'}, {'measure': 'Postoperative pain score at rest', 'timeFrame': 'Forty-eight hours after caesarean delivery', 'description': 'The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.'}, {'measure': 'Postoperative pain score with movement', 'timeFrame': 'Two hours after caesarean delivery', 'description': 'The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.'}, {'measure': 'Postoperative pain score with movement', 'timeFrame': 'Four hours after caesarean delivery', 'description': 'The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.'}, {'measure': 'Postoperative pain score with movement', 'timeFrame': 'Eight hours after caesarean delivery', 'description': 'The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.'}, {'measure': 'Postoperative pain score with movement', 'timeFrame': 'Twelve hours after caesarean delivery', 'description': 'The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.'}, {'measure': 'Postoperative pain score with movement', 'timeFrame': 'Twenty-four hours after caesarean delivery', 'description': 'The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.'}, {'measure': 'Postoperative pain score with movement', 'timeFrame': 'Forty-eight hours after caesarean delivery', 'description': 'The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.'}, {'measure': 'number of rescue analgesics required', 'timeFrame': 'within Forty-eight hours of surgery', 'description': 'The number of rescue analgesics required within 48 h of surgery was recorded'}], 'secondaryOutcomes': [{'measure': 'systolic blood pressure (SBP)', 'timeFrame': 'Two hours after caesarean delivery', 'description': "Patient's systolic blood pressure (SBP)"}, {'measure': 'systolic blood pressure (SBP)', 'timeFrame': 'Four hours after caesarean delivery', 'description': "Patient's systolic blood pressure (SBP)"}, {'measure': 'systolic blood pressure (SBP)', 'timeFrame': 'Eight hours after caesarean delivery', 'description': "Patient's systolic blood pressure (SBP)"}, {'measure': 'systolic blood pressure (SBP)', 'timeFrame': 'Twelve hours after caesarean delivery', 'description': "Patient's systolic blood pressure (SBP)"}, {'measure': 'systolic blood pressure (SBP)', 'timeFrame': 'Twenty-four hours after caesarean delivery', 'description': "Patient's systolic blood pressure (SBP)"}, {'measure': 'systolic blood pressure (SBP)', 'timeFrame': 'Forty-eight hours after caesarean delivery', 'description': "Patient's systolic blood pressure (SBP)"}, {'measure': 'diastolic blood pressure (DBP)', 'timeFrame': 'Two hours after caesarean delivery', 'description': "Patient's diastolic blood pressure (DBP)"}, {'measure': 'diastolic blood pressure (DBP)', 'timeFrame': 'Four hours after caesarean delivery', 'description': "Patient's diastolic blood pressure (DBP)"}, {'measure': 'diastolic blood pressure (DBP)', 'timeFrame': 'Eight hours after caesarean delivery', 'description': "Patient's diastolic blood pressure (DBP)"}, {'measure': 'diastolic blood pressure (DBP)', 'timeFrame': 'Twelve hours after caesarean delivery', 'description': "Patient's diastolic blood pressure (DBP)"}, {'measure': 'diastolic blood pressure (DBP)', 'timeFrame': 'Twenty-four hours after caesarean delivery', 'description': "Patient's diastolic blood pressure (DBP)"}, {'measure': 'diastolic blood pressure (DBP)', 'timeFrame': 'Forty-eight hours after caesarean delivery', 'description': "Patient's diastolic blood pressure (DBP)"}, {'measure': 'heart rate (HR)', 'timeFrame': 'Two hours after caesarean delivery', 'description': "Patient's heart rate (HR)"}, {'measure': 'heart rate (HR)', 'timeFrame': 'Four hours after caesarean delivery', 'description': "Patient's heart rate (HR)"}, {'measure': 'heart rate (HR)', 'timeFrame': 'Eight hours after caesarean delivery', 'description': "Patient's heart rate (HR)"}, {'measure': 'heart rate (HR)', 'timeFrame': 'Twelve hours after caesarean delivery', 'description': "Patient's heart rate (HR)"}, {'measure': 'heart rate (HR)', 'timeFrame': 'Twenty-four hours after caesarean delivery', 'description': "Patient's heart rate (HR)"}, {'measure': 'heart rate (HR)', 'timeFrame': 'Forty-eight hours after caesarean delivery', 'description': "Patient's heart rate (HR)"}, {'measure': 'Blood oxygen saturation (SpO2)', 'timeFrame': 'Two hours after caesarean delivery', 'description': 'Measurement of pulse Blood oxygen saturation (SpO2) in parturients'}, {'measure': 'Blood oxygen saturation (SpO2)', 'timeFrame': 'Four hours after caesarean delivery', 'description': 'Measurement of pulse Blood oxygen saturation (SpO2) in parturients'}, {'measure': 'Blood oxygen saturation (SpO2)', 'timeFrame': 'Eight hours after caesarean delivery', 'description': 'Measurement of pulse Blood oxygen saturation (SpO2) in parturients'}, {'measure': 'Blood oxygen saturation (SpO2)', 'timeFrame': 'Twelve hours after caesarean delivery', 'description': 'Measurement of pulse Blood oxygen saturation (SpO2) in parturients'}, {'measure': 'Blood oxygen saturation (SpO2)', 'timeFrame': 'Twenty-four hours after caesarean delivery', 'description': 'Measurement of pulse Blood oxygen saturation (SpO2) in parturients'}, {'measure': 'Blood oxygen saturation (SpO2)', 'timeFrame': 'Forty-eight hours after caesarean delivery', 'description': 'Measurement of pulse Blood oxygen saturation (SpO2) in parturients'}, {'measure': 'Adverse events', 'timeFrame': 'within Forty-eight hours of surgery', 'description': 'Adverse events that occurred after the administration of study drugs were also recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecological; Surgery (Previous), Affecting Fetus or Newborn, Due to Obstructed Labor', 'Analgesia']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to determine whether the addition of esketamine to morphine would improve postoperative analgesia after caesarean section.\n\nParturients who planned for a caesarean delivery using combined spinal-epidural anaesthesia with a request for postoperative anaesthesia were randomly divided into four groups (A, B, C and D). When the surgery was completed, the parturients in groups A, B, C and D were administered 2 mg morphine, 0.25mg/kg of esketamine, 0.25mg/kg of esketamine plus 2 mg morphine sulfate and 0.25mg/kg of esketamine plus 1 mg morphine through the epidural catheters, respectively. The postoperative pain at rest, pain with movement, the number of rescue analgesics and adverse effects were evaluated for 48 h after caesarean delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '32 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* nulliparous parturients who scheduled for elective caesarean delivery under spinal-epidural anaesthesia;\n* parturients who had requested postoperative analgesia;\n* parturients aged between 20-35 years old;\n* parturients who had a full-term pregnancy;\n* parturients who were identified as having a singleton pregnancy; and\n* parturients who were categorised as having an American Society of Anaesthesiologists (ASA) physical status\n\nExclusion Criteria:\n\n* parturients with severe internal, surgical or obstetric comorbidities (including spinal deformities, hypertension, placental abruption, cholestasis in pregnancy, asthma, heart disease and abnormal coagulation parameters)\n* parturients with a known allergy to the drugs used in this study\n* parturients with severe mental illness who could not comply with doctors' instructions\n* parturients with chronic pain syndrome, which is defined as pain that persists for a period longer than 3 months"}, 'identificationModule': {'nctId': 'NCT05582135', 'briefTitle': 'Postoperative Analgesic Effect of Esketamine', 'organization': {'class': 'OTHER', 'fullName': "Xuanhan County People's Hospital"}, 'officialTitle': 'Epidural Esketamine and Morphine for Postoperative Analgesia After Caesarean Delivery: A Pilot Study', 'orgStudyIdInfo': {'id': 'XuanhanCo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'The parturients in group A were administered 2 mg morphine sulfate through the epidural catheter.', 'interventionNames': ['Drug: 2 mg morphine sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'The parturients in group B were administered 0.25mg/kg of esketamine.', 'interventionNames': ['Drug: 0.25mg/kg esketamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group C', 'description': 'The parturients in group C were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate.', 'interventionNames': ['Drug: 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group D', 'description': 'The parturients in group D were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate.', 'interventionNames': ['Drug: 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate']}], 'interventions': [{'name': '2 mg morphine sulfate', 'type': 'DRUG', 'description': 'The parturients were administered 2 mg morphine sulfate through the epidural catheter. Sterile saline was added to make a total volume of 8 mL.', 'armGroupLabels': ['group A']}, {'name': '0.25mg/kg esketamine', 'type': 'DRUG', 'description': 'The parturients were administered 0.25mg/kg of esketamine through the epidural catheter. Sterile saline was added to make a total volume of 8 mL.', 'armGroupLabels': ['group B']}, {'name': '0.25mg/kg of esketamine in combination with 2 mg morphine sulfate', 'type': 'DRUG', 'description': 'The parturients were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate through the epidural catheter. Sterile saline was added to all combinations of the analgesic drugs to make a total volume of 8 mL.', 'armGroupLabels': ['group C']}, {'name': '0.25mg/kg of esketamine in combination with 1 mg morphine sulfate', 'type': 'DRUG', 'description': 'The parturients were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate through the epidural catheter. Sterile saline was added to all combinations of the analgesic drugs to make a total volume of 8 mL.', 'armGroupLabels': ['group D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '636150', 'city': 'Dazhou', 'state': 'Sichuan', 'country': 'China', 'facility': 'Qijun Ran', 'geoPoint': {'lat': 31.2106, 'lon': 107.46308}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Xuanhan County People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}